Report: Mylan looks to block Ranbaxy from making generic Lipitor
NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.
Bloomberg reported that Mylan said in a complaint filed in federal court in Washington that because of past manufacturing violations at two of Ranbaxy’s factories in India, other companies should be able to launch versions of Lipitor (atorvastatin) once Pfizer’s patent expires in June. The FDA restricted certain imports from Ranbaxy’s plants in India in 2008 and 2009 after an inspection of plants in Dewas and Paonta Sahib turned up current good manufacturing practice violations there. The FDA also had found cGMP violations at the Paonta Sahib plant in 2006.
Ranbaxy, mostly owned by Japanese drug maker Daiichi Sankyo, has been slated to launch a generic version of Lipitor this year since 2008, under an agreement with Pfizer. Under FDA regulations, Ranbaxy would be entitled to six months in which to compete directly with Pfizer, after which the atorvastatin molecule would become fair game for any generic manufacturer. But Mylan is hoping to use Ranbaxy’s past cGMP violations to expedite the process.
A victory for Mylan would be a major loss for Ranbaxy given Lipitor’s status as the world’s top-selling drug, with annual sales of more than $7 billion in the United States alone, according to IMS Health.
In other news, Bloomberg reported that the Supreme Court rejected Mylan’s challenge to Daiichi Sankyo’s patent on the hypertension drugs Benicar (olmesartan) and Azor (olmesartan and amlodipine).
AAPCHO addresses diabetes with new program
OAKLAND, Calif. — The Association of Asian Pacific Community Health Organizations has introduced a program that aims to reduce the secondary complications of diabetes among specific ethnic groups living with the disease.
AAPCHO said its five-year diabetes program addresses diabetes among vulnerable populations in three Asian-American, Native Hawaiian and other Pacific Islander communities:
- In the Republic of the Marshall Islands by Ebeye Community Health Center;
- In Los Angeles by the Asian Pacific Health Care Venture; and
- In Waimanalo, Hawaii, by the Waimanalo Health Center.
Each program grantee is a community health center that provides healthcare services to medically underserved AA&NHOPI patients, many of whom are uninsured and low-income patients and have limited English proficiency.
The prevalence of diabetes among these ethnic groups continues to rise, AAPCHO noted.
"This program is unique for us in that its goal is to address diabetes more broadly, beyond just improving a diabetes patient’s health through the clinic or medical provider’s office," said Jeffrey Caballero, executive director of AAPCHO. "This program requires us to develop a broader collaborative strategy and network with more nontraditional partners to address diabetes not just at the individual patient level, but at the local community level."
PSE’s Rx-only switch in Arkansas opens a new can of worms
WHAT IT MEANS AND WHY IT’S IMPORTANT — The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn’t. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.
(THE NEWS: Arkansas PSE bill could spark fresh debate. For the full story, click here)
And that really opens a can of worms, because now dextromethorphan is being lumped together with PSE as “the other” OTC ingredient with a high abuse profile. Never mind that the issues surrounding each of these ingredients couldn’t be more disparate. And never mind the fact that the OTC industry voluntarily has stepped to the plate with paid-for programs to address each of these issues. Creating a streamlined rulemaking process absent any public stake in the outcome could place a whole host of appropriate OTC medicines in jeopardy — acetaminophen, for example, or nicotine-replacement therapy — just because the local newscasters stress the sexier headlines outlining the high-risk profile as opposed to the “less-than-sexy greater-benefit-versus-that-risk” storyline.
That aside, out-of-towners who are a bit under the weather are still out of luck if they want to buy a PSE product in the great state of Arkansas, if this bill becomes law, because pharmacists can only sell to those with an Arkansas-issued photo ID. The sole exception to that are military IDs; pharmacists can take those, too.
And if you’re sick and in search of some ready congestion relief, you may want to consider taking a quick shower and fixing up your hair before you go cold-remedy shopping. Because if you go into a pharmacy in Arkansas with bed head and the pharmacist mistakes you for a drug addict, well, you won’t be able to buy PSE then, either.
The only good news to come out of this proposed legislation is for law enforcement — real-time tracking of PSE purchases is still in play, and that means law enforcement still has a tool to identify the real bad guys in all of this — the actual meth cooks.
Except not all law enforcement sees this as good news. And that’s unfortunate, because as Arkansas Baxter County Sheriff John Montgomery testified, real-time electronic tracking works. The problem for some in law enforcement may be it works too well — fingering highly-likely meth addicts means an increase in meth lab busts. And how exactly do you propose to show progress in the war on meth if the number of your meth lab busts is on the incline as opposed to on the decline?